NCT06314243

The Impact of Pumpkin Seed Oil Supplementation on Hemodialysis Patients

The Impact of Pumpkin Seed Oil Supplementation on the Clinical Outcome in Hemodialysis Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the effects of Pumpkin Seed Oil (PSO) supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients. The main question it aims to answer is: • Does PSO have a promising effect on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients? Patients on regular hemodialysis who take PSO supplementation will be compared to those who don't to see if PSO supplementation improves their systemic inflammation, oxidative stress, and lipid profile.

Detailed description

This study aims to investigate the effects of PSO supplementation on systemic inflammation, oxidative stress, and lipid profile in hemodialysis patients via assessment of IL-6, MDA, lipid profile, and kidney function tests. Patients \& Methods: Design: Prospective, randomized, Open label - controlled clinical trial. Patients: A total of 56 patients on regular hemodialysis (HD) will be enrolled in the study. These patients will be randomly allocated into two equal groups: * Group 1 (PSO group): consists of 28 patients who will receive one capsule containing 1010 mg PSO once daily for 12 weeks, " Ronkin®, KMT PHARMA, Egypt. " * Group 2 (Control group): consists of 28 patients who will not receive the intervention. Setting: Adult Nephrology and Dialysis Unit, Ain Shams University Hospital, Cairo, Egypt. Blood samples will be taken in the dialysis unit and will be sent to Ain Shams University labs for analysis.

Conditions

• Hemodialysis Patients

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pumpkin Seed Oil " Ronkin®, KMT PHARMA, Egypt. "	Ronkin soft gelatin capsules, each containing 1010 mg of pumpkin seed oil (Latin name: Curcurbita pepo), standardized to contain palmitic acid (8-15%), stearic acid (3-8%), oleic acid (15-35%), linoleic acid (40-65%), and other fatty acids (≤ 2.4%)

Timeline

• Start date: 2024-09-04
• Primary completion: 2024-12-31
• Completion: 2025-07-10
• First posted: 2024-03-18
• Last updated: 2025-08-06

Locations

1 site across 1 country: Egypt